FDA Approves Medtronic Heart Device

KARREN MILLSJune 27, 2002

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MINNEAPOLIS (AP) _ Medtronic Inc. said Thursday that it has received U.S. Food and Drug Administration approval to sell its device that both resynchronizes an irregular heartbeat and delivers a shock to slow a racing heartbeat.

The Medtronic InSync ICD system pairs a defibrillator with a heart-synchronization device to treat the two most fatal types of heart ailments _ the heart’s failure to pump adequate amounts of blood and sudden cardiac death that results when the heart abruptly stops beating.

The FDA approved a similar system made by Indianapolis-based Guidant Corp. in May, and St. Jude Medical Inc., based in Little Canada, is conducting clinical trials on such a device.

``I think there’s really no first mover advantage in the marketplace,″ said Jan David Wald, an analyst with A.G. Edwards, noting that Medtronic has a very strong sales and marketing team.

``They have a lot of muscle that they can exercise when needed, and I think they will,″ Wald said.

The main difference between the two approved devices is that Medtronic’s device uses fewer shocks to slow a rapidly beating heart.

The Medtronic system also offers physicians a number of leads for inserting the device, allowing for differences in anatomy, Wald said, while Guidant’s system has a single lead.

Guidant’s system is priced at $35,000 to $40,000 and Wald said he expects Medtronic’s system to be similarly priced.

``I think you’re going to see a larger number of these devices used _ even though they’re more expensive than just pacing devices _ than perhaps some people are anticipating,″ because of the defibrillator backup, Wald said.

In trading on the New York Stock Exchange, Medtronic shares rose 5.5 percent, or $2.24 a share, to $43.30 while Guidant shares gained 5.4 percent, or $1.58 a share, to $30.79.

Unlike a heart attack, heart failure is a condition that typically develops slowly. When the heart is not pumping properly, even mild activity can cause shortness of breath or difficulty breathing.

Cardiac resynchronization therapy is designed to coordinate the contraction of the heart’s two lower chambers and improve the heart’s efficiency to increase blood flow to the body.

Heart failure is the most rapidly growing form of cardiovascular disease, Medtronic said, with 5 million Americans already diagnosed and the number expected to double by 2007.

Heart failure, which also is responsible for more hospitalizations in than all types of cancer combined, costs the health care industry an estimated $40 billion to manage, the Fridley-based company said.

The InSync ICD system is approved for treating heart failure patients with lower heart chambers where beating is not synchronized and who are also at risk for potentially lethal ventricular arrhythmias that could lead to sudden cardiac arrest. In patients diagnosed with heart failure, sudden cardiac arrest occurs at six to nine times the rate of the general population, Medtronic said.